Clinical Trial: Prevention Recurrent Otitis Media in the Young Children
Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Effect of Adenotomy and Tympanostomy on Preventing Recurrent Otitis Media in the Young Children
Brief Summary: The purpose of this study is to find out if young children have more benefit of the combination of adenotomy and tympanostomy than plain tympanostomy in prevention of recurrent otitis media.
Detailed Summary:
Recurrent otitis media is the most common bacterial disease in young children. Many risk factors are known, but benefit of operations are conflicting in children under two years of age.
In this randomized prospective controlled trial, the effect of tympanostomy tubes is compared to the effect of the combination of adenotomy and tympanostomy tubes in preventing recurrent otitis media. A control group with no active treatment is also included. The speed of recovery is studied by recording the daily symptoms and number of days of effusion comparing the differences between the groups. Life quality issues are recorded preoperatively and at about four and twelve months after the operation and are compared between the groups and to healthy children of the same age.
Sponsor: Oulu University Hospital
Current Primary Outcome:
- - number of acute otitis media
- - quality of life issues
Original Primary Outcome: Same as current
Current Secondary Outcome:
- - time to first recurrence
- - speed of recovery of each otitis media
- - number of days of middle ear effusion
- - number of upper respiratory infections
- - prevention of otitis media caused by pnemococcus in carrier of pneumococcus
Original Secondary Outcome: Same as current
Information By: Oulu University Hospital
Dates:
Date Received: September 10, 2005
Date Started: February 2002
Date Completion: August 2005
Last Updated: December 20, 2005
Last Verified: February 2002
